Cinnal-f®


(follitropin alfa)

The Right Choice for Fertility


Cinnal-F (Follitropin alpha)

Cinnal-f® 450 IU, 1 Sterile Pre-filled pen (0.75 ml)

Cinnal-f® 900 IU, 1 Sterile Pre-filled pen (1.5 ml)

Cinnal-f® 75 IU, 1 vial of powder for reconstitution, 1 ampoule of solvent contains 1 ml water for injection

What is Cinnal-F?

 

Cinnal-f® (Follitropin alfa) is a recombinant DNA origin based hormone identical to follicle-stimulating hormone (FSH) produced by the pituitary gland. FSH helps to develop eggs in the ovaries.

Cinnal-f® is used as a fertility medicine to develop eggs in women who have not been able to become pregnant because of problems in ovulation.

Cinnal-f® is also used as a fertility medicine to help men with low sperm counts produce more sperms.

What is Cinnal-f used for?

• It is used to help women get pregnant.

• It is used to help make sperm.

It may be given to you for other reasons. Talk with the doctor.

What should I know BEFORE taking Cinnal-F?

If you have an allergy to follitropin alfa or any other part of this drug.

If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs

If you have any of these health problems: Adrenal gland disease, brain tumor, pituitary gland disease, or thyroid gland disease, a tumor in your female organs, enlarged ovaries or ovarian cysts, or vaginal bleeding where the cause is not known, urinary tract bleeding, heavy or irregular bleeding from your uterus or vagina, permanent damage to the testes, blood-clotting problems or breathing problems (eg, asthma)

If you are pregnant or may be pregnant. Do not take this drug if you are pregnant.

Your doctor will do blood/medical tests (e.g., estradiol blood levels, ultrasound) to find the right dose for you and to decide when to inject the next medication (hCG).

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

How should I take Cinnal-F?

 

  • Cinnal-f® is usually administered as an injection at your doctor's office, hospital, or clinic. You can use it at home if you were learnt how to use it and by permission of your doctor.
  • This medicine comes with a Patient Information Leaflet. Read it carefully.
  • Understand and use the proper method of preparing the medicine if you are going to prepare, Learn all preparation and usage instructions in the product package
  • Make sure you clearly understand and carefully follow your doctor's instructions how to give yourself an injection, including using the proper needle and syringe.
  • Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid.
  • One or more vials of Cinnal-f® should be dissolved in one mL of Sterile Water for Injection, (concentration should not exceed 225 IU/0.5 mL) and administered subcutaneously immediately.
  • Dosage and length of treatment are based on your medical condition and response to treatment. Your doctor will do blood/medical tests (e.g., estradiol blood levels, ultrasound) to find the right dose for you and to decide when to inject the next medication (hCG).
  • Remember to rotate the site of injections to different areas to prevent skin problems.
  • Throw away needles, syringes, bottles, and unused medicine after the injection in a safe manner.
  • If you miss a dose of Cinnal-f®, contact your doctor right away.
  • If you think there has been an overdose, call your poison control center or get medical care right away.
  • If you have any question, ask your doctor or call us at CinnaGen’s patient support center(+9821-42593) for nursery and free education in your city.
  • Tell your doctor when you use the last dose of Cinnal-f®. Cinnal-f® often requires that another hormone called human chorionic gonadotropin (hCG) to be given as a single dose the day after the last dose of Cinnal-f®.

Instruction for using Cinnal-f® pen:

 

  1. Take the pen out of refrigerator and wait until it reaches room temperature.
  2. Wash your hands with water and soap.
  3. The preferred injection sites are tighs and abdomen. (As it is shown in figure 3). Rotate the injection site with every injection
  4. Hold the Pen in one hand. Remove the Cap by pulling with the other hand.
  5. Wipe the pen’s septum with an alcohol swab.
  6. Pull off the paper tab from the back of the needle. While the outer needle shield still attached, place the needle on the pen and rotate clockwise to fix it on the pen. Use a new needle for every injection.
  7. Pull to remove needle outer shield. You will need needle outer shield to remove the needle after injection is finished.
  8. Gently remove the inner needle shield and throw it away. Hold your pen with the needle pointing up.
  9. In the first use, rotate the dose dialer until “2” aligns with the pointer in the dose displaying window.
  10. Tap the cartridge gently with your finger to help air bubbles rise to the top. Some small bubbles may remain in the cartridge.
  11. Press the thumb button until “0” aligns with the pointer in the dose displaying window. If you saw a drop of liquid come out of the needle, it means the pen is ready to use. If nothing comes out of the tip, repeat steps 9 to 11. If the problem does not resolve after four attempts, switch with a new needle. If the problem continues to exist, contact CinnaGen patient support center.
  12. Rotate the dose dialer until number “8” appears in the dose displaying window.
  13. Rub the injection site with an alcohol swab.
  14. Insert the needle straight into the skin at a 90-degree angle.
  15. Press the thumb button till number “0” appears in the dose displaying window.
  16. Hold the thumb button down and count slowly to 6 to ensure that the medicine has completely injected into the skin. Remove the needle out of your skin when you finished counting.
  17. Carefully replace the outer needle shield on the needle. Rotate the capped needle counterclockwise. Properly discard both the needle and the outer needle shield as directed by your healthcare professional.
  18. Put the cap on the pen.

What should I know while taking Cinnal-F?

Tell dentists, surgeons, and other doctors that you use this drug.

Safe and effective use of Cinnal-f® requires monitoring of ovarian response with serum estradiol and vaginal ultrasound on a regular basis.

This drug may raise the chance of getting pregnant with more than one baby.  

The chance of pregnancy outside of the uterus (ectopic pregnancy) may be raised in some women. Talk with your doctor.

Limit working out while undergoing ovarian stimulation. Talk with your doctor.

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Acne, breast pain or growth, discomfort at the injection site, headache, sinus infection, stomach upset, tiredness

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider or us at CinnaGen. Call your doctor for medical advice about side effects. 

 

Pregnancy and lactation

X, this means Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits

It is not known whether this drug is excreted in human milk. Decision should be made by your doctor whether to discontinue nursing or to discontinue the drug

How should I store Cinnal-F?

Keep out of reach of children.

Cinnal-f® should be stored at 2-8˚C.

Cinnal-f® should not be used, after the expiry date on the label. Cinnal-f® should not be exposed to direct light.

Any unused portion of Cinnal-f® vial should be discarded.

Do not use the medicine if it is not clear or you can see particles floating in it.

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